FDA-Device2014-12-31Class II
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
Natus Medical Incorporated
Hazard
Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the original device. While some customers may prefer using these lights at the higher intensity levels, some are concerned that patients may receive more intensity than desired.
Sold states
worldwide
Affected count
1907 total (1413 in US and 494 international)
Manufactured in
5900 1st Ave S, Seattle, WA, United States
Products
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0847-2015Don't want to check this manually?
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